FDA places partial clinical hold on PepGen’s FREEDOM2-DM1 trial

Reuters03-05
FDA places partial clinical hold on PepGen’s FREEDOM2-DM1 trial

PepGen Inc. said the U.S. Food and Drug Administration has placed a partial clinical hold on the U.S. portion of its FREEDOM2-DM1 Phase 2 trial of PGN-EDODM1 for myotonic dystrophy type 1, citing questions related to previously submitted preclinical pharmacology and toxicology studies. The company said the hold was not based on blinded Phase 1 clinical data, no U.S. patients have been enrolled in FREEDOM2, and it is submitting additional analyses, including recently unblinded FREEDOM data, to address the FDA’s concerns.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. PepGen Inc. published the original content used to generate this news brief via Business Wire (Ref. ID: 20260304006219) on March 04, 2026, and is solely responsible for the information contained therein.

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